Editorial Policy and Regulatory Review Process

This policy applies to all editorial content published on matrixone.health, including our blog, guides, and resource library.

Our commitment

Matrix One builds software for teams that develop regulated medical devices and diagnostics. The people who read our content make decisions that affect patient safety and regulatory compliance, so we hold our editorial content to a high standard. This page explains how we create that content, who reviews it, where our information comes from, and how to tell us when we get something wrong.

Our principles

• Accuracy. Our content is grounded in primary regulatory sources and current standards. Where a topic is unsettled or open to interpretation, we say so rather than presenting one reading as fact.

• Independence. Our editorial content is written to inform, not to sell. Where an article discusses one of our products, we make that context clear.

• Expertise. Content on regulatory and quality topics is written by people with real experience in the field, and it is attributed to a named author.

• Transparency. Every article shows who wrote it and when it was last reviewed. Our sources are available on request.

• Serving the reader. We write for the professional doing the work. Clarity for that reader comes before everything else.

Who writes our content

Our articles are written and reviewed by named contributors with backgrounds in regulatory affairs, quality management, software development, and the medical device industry. Each author has a public profile listing their role and experience. You can see our contributors on our Authors page.

Where our information comes from

We base our content on primary and authoritative sources, including:

• Regulations and guidance from bodies such as the FDA, the European Commission, and national competent authorities

• Recognised standards, including ISO 13485, ISO 14971, IEC 62304, and IEC 62366

• Published guidance from notified bodies and standards organisations

• The direct experience of practitioners working in the industry

Where we reference a regulation or standard, we aim to link to or cite the source so you can verify it yourself.

Use of AI

We may use AI tools to assist with drafting or research. Any content produced with AI assistance is reviewed and verified by a human expert before publication, and is held to the same standard as all other content.

This is not regulatory or legal advice

Our content is educational. It is not a substitute for formal regulatory, legal, or notified body advice, and it does not create a consulting relationship. Always confirm your obligations against the current regulation and, where needed, with a qualified professional.

Corrections and feedback

If you spot something inaccurate or out of date, tell us and we will look into it at marketing.matrix@matrixreq.com. When we correct a material error, we update the article and its review date.